MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-02-20 for VISUMAX LASER KERATOME N/A 000000-1345-518 manufactured by Carl Zeiss Meditec Ag (jena).
[185949437]
The hcp reported that his technician put the wrong cylinder data into the visumax. The technician entered the value of the cylinder with the wrong algebraic sign (+ instead of -). According to the instructions for use the operator of the device has to check carefully the surgical parameters. Laser treatment is not to be started until all parameters are correct.
Patient Sequence No: 1, Text Type: N, H10
[185949438]
A healthcare professional (hcp) reported that a patient had been treated with the wrong amount of astigmatism using the visumax device. The hcp will be performing an additional procedure to correct the patient's vision.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615030-2020-00004 |
| MDR Report Key | 9734987 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-02-20 |
| Date of Report | 2020-01-24 |
| Date of Event | 2020-01-24 |
| Date Mfgr Received | 2020-01-24 |
| Device Manufacturer Date | 2018-01-23 |
| Date Added to Maude | 2020-02-20 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. VERNON BROWN |
| Manufacturer Street | 5160 HACIENDA DRIVE |
| Manufacturer City | DUBLIN, CA |
| Manufacturer Country | US |
| Manufacturer Phone | 5574689 |
| Manufacturer G1 | CARL ZEISS MEDITEC AG (JENA) |
| Manufacturer Street | CARL ZEISS PROMENADE 10 |
| Manufacturer City | JENA, THUERINGIA |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VISUMAX LASER KERATOME |
| Generic Name | FEMTOSECOND LASER SYSTEM FOR REFRACTIVE CORRECTION |
| Product Code | OTL |
| Date Received | 2020-02-20 |
| Model Number | N/A |
| Catalog Number | 000000-1345-518 |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARL ZEISS MEDITEC AG (JENA) |
| Manufacturer Address | CARL ZEISS PROMENADE 10 JENA, THUERINGIA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-20 |